2013 Mitral Valve Conclave

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

tsnews@frontlinemedcom.com

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

tsnews@frontlinemedcom.com

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

tsnews@frontlinemedcom.com

NEW YORK – In a group of 351 high-risk surgical patients with severe mitral regurgitation (grade 3 or 4) at baseline, more than 80% were alive 1 year after transcatheter treatment with the MitraClip device if their MR was well controlled (MR grade 1+ or 2+), compared with 58% survival for those with persistent severe MR.

These results from the EVEREST II High Surgical Risk cohort were presented by Dr. Paul A. Grayburn at the 2013 Mitral Valve Conclave.

The presentation was chosen as one of the Plenary "Top 10" Abstract Presentations at the meeting.

"Many high-risk surgical patients do not undergo mitral valve surgery and therefore have no therapeutic option for MR. Percutaneous repair with MitraClip is an option for selected patients with suitable anatomy who are too high of a risk for surgery. In this study, we found that the extent of clinical benefit observed corresponds with the degree of MR reduction achieved," said Dr. Grayburn, a cardiologist at the Baylor Heart and Vascular Institute in Dallas. "MR reduction to 1+ or 2+ results in significant clinical and symptomatic improvement."

The MitraClip is a catheter-based valve repair system intended to reduce MR. The device is inserted via the femoral vein using a guide catheter, and the MitraClip implant is attached directly to the mitral valve. On March 20, 2013, the FDA’s Circulatory System Devices Advisory Panel voted by a narrow margin (5-3) in favor of the device, finding that the benefits outweighed the risks.

Data were pooled from the EVEREST II High Risk Study and the EVEREST II REALISM Continued Access Study. The mean age of the 351 patients was 76 years, with 58% of the group over age 75. At baseline, patients had significant comorbidities, including 82% with coronary artery disease, 51% with a prior myocardial infarction, 69% with a history of atrial fibrillation, and 60% with previous cardiovascular surgery. Of the 98% with heart failure, 85% were New York Heart Association (NYHA) functional class III/IV. Aside from cardiac problems, 31% had moderate to severe renal disease, and 29% had chronic obstructive pulmonary disease. Functional MR was present in 70% of the group.

With these health problems in mind, the patients were considered to be at high risk for mitral valve surgery as indicated by a Society of Thoracic Surgeons (STS) risk calculator operative mortality of 12% or more.

Mortality at 1 year was 22.8%. Looking at freedom from mortality at 1 year after treatment, 80.9% of those discharged with MR greater than or equal to 1+ and 80.3% of those discharged with an MR grade of 2+ were alive. For those discharged with a grade of 3+ or 4+, 58.4% were alive (P = .0003).

"As you can see, it is not good for you to leave the operating room after MitraClip with an MR grade of 3+ or 4+," Dr. Grayburn said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Residual MR grade also influenced other measures. For instance, patients with low levels of MR showed better left ventricular remodeling, as measured by larger changes from baseline in left ventricular end diastolic volume (LVEDV) and left ventricular systolic volume. For LVEDV, there was a 15% reduction from baseline in the group with MR greater than or equal to 1+ and a 10% reduction in the 2+ group, but no statistically significant reduction in the 3+/4+ groups.

After treatment, significantly fewer patients with an MR grade greater than or equal to 1+ were considered NYHA functional class III/IV, compared with those with MR 3+ or 4+.

Other benefits of treatment included a 54% reduction in the annual rate of hospitalization due to congestive heart failure in the 12 months after the MitraClip procedure vs. the 12 months pre-MitraClip in patients with an MR grade of 2+ at discharge, compared with no change in hospitalization rate in those discharged with MR greater than 2+. Trends were noted between better MR control and scores on the Short Form-36 (SF-36) quality of life score and the mental component score.

Dr. Grayburn emphasized that the MitraClip procedure is not for everybody but offers an option for those considered at high risk. "If you can operate on these patients, you should; then you can get their MR to null. This device is really a palliative offering for those turned down by a mitral valve surgeon at an experienced mitral valve center. At our center, many patients referred to us for MitraClip actually end up getting surgery because they turn out to be surgical candidates." At his center, Dr. Grayburn says that for every patient who gets a MitraClip, two undergo surgery.

Nevertheless, Dr. Grayburn believes that some high-risk patients who might benefit from MitraClip are unaware of this alternative. "We haven’t figured out how to capture patients with severe symptomatic MR in the general internist’s or even cardiologist’s office."

Dr. Grayburn received research support from Abbott Vascular.

NEW YORK – In a group of 351 high-risk surgical patients with severe mitral regurgitation (grade 3 or 4) at baseline, more than 80% were alive 1 year after transcatheter treatment with the MitraClip device if their MR was well controlled (MR grade 1+ or 2+), compared with 58% survival for those with persistent severe MR.

These results from the EVEREST II High Surgical Risk cohort were presented by Dr. Paul A. Grayburn at the 2013 Mitral Valve Conclave.

The presentation was chosen as one of the Plenary "Top 10" Abstract Presentations at the meeting.

"Many high-risk surgical patients do not undergo mitral valve surgery and therefore have no therapeutic option for MR. Percutaneous repair with MitraClip is an option for selected patients with suitable anatomy who are too high of a risk for surgery. In this study, we found that the extent of clinical benefit observed corresponds with the degree of MR reduction achieved," said Dr. Grayburn, a cardiologist at the Baylor Heart and Vascular Institute in Dallas. "MR reduction to 1+ or 2+ results in significant clinical and symptomatic improvement."

The MitraClip is a catheter-based valve repair system intended to reduce MR. The device is inserted via the femoral vein using a guide catheter, and the MitraClip implant is attached directly to the mitral valve. On March 20, 2013, the FDA’s Circulatory System Devices Advisory Panel voted by a narrow margin (5-3) in favor of the device, finding that the benefits outweighed the risks.

Data were pooled from the EVEREST II High Risk Study and the EVEREST II REALISM Continued Access Study. The mean age of the 351 patients was 76 years, with 58% of the group over age 75. At baseline, patients had significant comorbidities, including 82% with coronary artery disease, 51% with a prior myocardial infarction, 69% with a history of atrial fibrillation, and 60% with previous cardiovascular surgery. Of the 98% with heart failure, 85% were New York Heart Association (NYHA) functional class III/IV. Aside from cardiac problems, 31% had moderate to severe renal disease, and 29% had chronic obstructive pulmonary disease. Functional MR was present in 70% of the group.

With these health problems in mind, the patients were considered to be at high risk for mitral valve surgery as indicated by a Society of Thoracic Surgeons (STS) risk calculator operative mortality of 12% or more.

Mortality at 1 year was 22.8%. Looking at freedom from mortality at 1 year after treatment, 80.9% of those discharged with MR greater than or equal to 1+ and 80.3% of those discharged with an MR grade of 2+ were alive. For those discharged with a grade of 3+ or 4+, 58.4% were alive (P = .0003).

"As you can see, it is not good for you to leave the operating room after MitraClip with an MR grade of 3+ or 4+," Dr. Grayburn said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Residual MR grade also influenced other measures. For instance, patients with low levels of MR showed better left ventricular remodeling, as measured by larger changes from baseline in left ventricular end diastolic volume (LVEDV) and left ventricular systolic volume. For LVEDV, there was a 15% reduction from baseline in the group with MR greater than or equal to 1+ and a 10% reduction in the 2+ group, but no statistically significant reduction in the 3+/4+ groups.

After treatment, significantly fewer patients with an MR grade greater than or equal to 1+ were considered NYHA functional class III/IV, compared with those with MR 3+ or 4+.

Other benefits of treatment included a 54% reduction in the annual rate of hospitalization due to congestive heart failure in the 12 months after the MitraClip procedure vs. the 12 months pre-MitraClip in patients with an MR grade of 2+ at discharge, compared with no change in hospitalization rate in those discharged with MR greater than 2+. Trends were noted between better MR control and scores on the Short Form-36 (SF-36) quality of life score and the mental component score.

Dr. Grayburn emphasized that the MitraClip procedure is not for everybody but offers an option for those considered at high risk. "If you can operate on these patients, you should; then you can get their MR to null. This device is really a palliative offering for those turned down by a mitral valve surgeon at an experienced mitral valve center. At our center, many patients referred to us for MitraClip actually end up getting surgery because they turn out to be surgical candidates." At his center, Dr. Grayburn says that for every patient who gets a MitraClip, two undergo surgery.

Nevertheless, Dr. Grayburn believes that some high-risk patients who might benefit from MitraClip are unaware of this alternative. "We haven’t figured out how to capture patients with severe symptomatic MR in the general internist’s or even cardiologist’s office."

Dr. Grayburn received research support from Abbott Vascular.

NEW YORK – In a group of 351 high-risk surgical patients with severe mitral regurgitation (grade 3 or 4) at baseline, more than 80% were alive 1 year after transcatheter treatment with the MitraClip device if their MR was well controlled (MR grade 1+ or 2+), compared with 58% survival for those with persistent severe MR.

These results from the EVEREST II High Surgical Risk cohort were presented by Dr. Paul A. Grayburn at the 2013 Mitral Valve Conclave.

The presentation was chosen as one of the Plenary "Top 10" Abstract Presentations at the meeting.

"Many high-risk surgical patients do not undergo mitral valve surgery and therefore have no therapeutic option for MR. Percutaneous repair with MitraClip is an option for selected patients with suitable anatomy who are too high of a risk for surgery. In this study, we found that the extent of clinical benefit observed corresponds with the degree of MR reduction achieved," said Dr. Grayburn, a cardiologist at the Baylor Heart and Vascular Institute in Dallas. "MR reduction to 1+ or 2+ results in significant clinical and symptomatic improvement."

The MitraClip is a catheter-based valve repair system intended to reduce MR. The device is inserted via the femoral vein using a guide catheter, and the MitraClip implant is attached directly to the mitral valve. On March 20, 2013, the FDA’s Circulatory System Devices Advisory Panel voted by a narrow margin (5-3) in favor of the device, finding that the benefits outweighed the risks.

Data were pooled from the EVEREST II High Risk Study and the EVEREST II REALISM Continued Access Study. The mean age of the 351 patients was 76 years, with 58% of the group over age 75. At baseline, patients had significant comorbidities, including 82% with coronary artery disease, 51% with a prior myocardial infarction, 69% with a history of atrial fibrillation, and 60% with previous cardiovascular surgery. Of the 98% with heart failure, 85% were New York Heart Association (NYHA) functional class III/IV. Aside from cardiac problems, 31% had moderate to severe renal disease, and 29% had chronic obstructive pulmonary disease. Functional MR was present in 70% of the group.

With these health problems in mind, the patients were considered to be at high risk for mitral valve surgery as indicated by a Society of Thoracic Surgeons (STS) risk calculator operative mortality of 12% or more.

Mortality at 1 year was 22.8%. Looking at freedom from mortality at 1 year after treatment, 80.9% of those discharged with MR greater than or equal to 1+ and 80.3% of those discharged with an MR grade of 2+ were alive. For those discharged with a grade of 3+ or 4+, 58.4% were alive (P = .0003).

"As you can see, it is not good for you to leave the operating room after MitraClip with an MR grade of 3+ or 4+," Dr. Grayburn said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Residual MR grade also influenced other measures. For instance, patients with low levels of MR showed better left ventricular remodeling, as measured by larger changes from baseline in left ventricular end diastolic volume (LVEDV) and left ventricular systolic volume. For LVEDV, there was a 15% reduction from baseline in the group with MR greater than or equal to 1+ and a 10% reduction in the 2+ group, but no statistically significant reduction in the 3+/4+ groups.

After treatment, significantly fewer patients with an MR grade greater than or equal to 1+ were considered NYHA functional class III/IV, compared with those with MR 3+ or 4+.

Other benefits of treatment included a 54% reduction in the annual rate of hospitalization due to congestive heart failure in the 12 months after the MitraClip procedure vs. the 12 months pre-MitraClip in patients with an MR grade of 2+ at discharge, compared with no change in hospitalization rate in those discharged with MR greater than 2+. Trends were noted between better MR control and scores on the Short Form-36 (SF-36) quality of life score and the mental component score.

Dr. Grayburn emphasized that the MitraClip procedure is not for everybody but offers an option for those considered at high risk. "If you can operate on these patients, you should; then you can get their MR to null. This device is really a palliative offering for those turned down by a mitral valve surgeon at an experienced mitral valve center. At our center, many patients referred to us for MitraClip actually end up getting surgery because they turn out to be surgical candidates." At his center, Dr. Grayburn says that for every patient who gets a MitraClip, two undergo surgery.

Nevertheless, Dr. Grayburn believes that some high-risk patients who might benefit from MitraClip are unaware of this alternative. "We haven’t figured out how to capture patients with severe symptomatic MR in the general internist’s or even cardiologist’s office."

Dr. Grayburn received research support from Abbott Vascular.

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the 2013 Mitral Valve Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the 2013 Mitral Valve Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the 2013 Mitral Valve Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.